STANFORD UN!VE RY I?Y. STANFO RID, GALIF0 RNIA H4306 DEPARTPENT OF DIOLOGICAL~ SCIENCES GHARLES YKeearch and the present N1:i Guide- I ines. Donald S. Fredrickson, M.D. April 12, 1977 page -2- restrictions whatsoever on most work which 5s presently classified as Pi or P2-level researtti. It is unrealistic to ask scientists to follow unnecessarily strict procedural precautions in their research when, on the basis of the experience of years of resesrch, they are convinced that no hazard exists. Most P1 and P2 level recombinant DNA zesearch is not significantly distinguishable from genetic research performed over the past 30 years with viruses, bacteria, yeasts and molds. For us to consider it different is hypocrisy. instance of the appearance of a novel pathogen from this prior genetic research. To my knowledge there is cot a single The dangers which have been iimgined by mme a-e no greater, ia r?y cpkior., than the iikeiihood that laboratory mutants of commori bacterial viruses such as @X174 or P22, or a mutanc fruit5ly released into the envirorment, or a pot of soiip allowed to spoil, will do us all in. FurthcmLore, rhere is no factual basis for the most serious theoretical o3jectia-i that: has been raised - the suggestion that there is a barrier between prokaryotes and eukaryotes pre.venting DXA interchange. and simple, and everything sc.ien';ific we know about the basis of evolution suggests that prokaryotes and eukaryotes have exercised. the mple oppor- tunities tliey have had to exchange their DNA fer mi.LlFons of years. The recent discovery thgt at. least soz'ilc elikarjTote genes arc expressed in pro- karyotes stiggests that fundamma1 biologi.ca7. processes are quite sjniilar in both g1:orips 02 organisms. In sddition, the existence of transniissible plasmids and transposable. genetic elements in lower and Iiighe;: organisms argues convincingly that nature Iias, for some time, prac.ticed reconioin;mt DNA techniques. This is a mystical view, pure If one walks through the halls of any hospital the & conceixis of Iiumsns become obvious, It is ironic that at the first time in the history of medical research when we have the capability of studying defective human genes, thcre is cry by a few to ban such research. In my view, the combined techniques of DNA cloning, restriction eazyiiie analysis and DXA sequeqciug are so powerful and 02 such Smeasurablt potential beneiir with little oz IIC\ conpeieble rFs!. , :hie Lt will 5ecor.w virtually i1itpossilI.e fcr any molecuLar biologisr to avoid using them in hLs or her resear&; riot: to do so T?OU~~ seriously impair our ability f-o deal wJS t-h many of the problems which face our society, I therefore feel tha; it is extremely importanr that conceivable risks be assessed more realistically than tliey havc, in proposi.ng appropriate conrain- ment conditions. The present Guidrlines ask scientists to discard what they believe as fact based on years of experience and training, and, in the absence of any nextl infomat-ion or insights, to adopt an unrealistic and arbitrarily deteniiiized code OF bctmvior, f feel compelled to urge as 1)onaTd S. Fredrickson, MeD. April 12, 1977 page -3- strongly as 1 caD that you reexamine the Guidelines and at a minimum recormend the removal of all restrictions and the requirement for certifi.catiort, for all recombinant DNA research that is prespntly classified as PI, as well. as recom- binant DHA researdi involving the fusion of IiXA of nm-qmchogenic microorganisms. Unless you do I fear that, by anafngy, a7.1 biological research will shortly be ju6ged potentially hazardous and will be subjected to progress-stifling coiitrois. The Kcene 'Dill introditced in the Calirornia Assembly is R case in point and would in fact pl.acc strict: Controls on all bLologicaL research, In my opinion, tbe EEL kidelines aad ttleir requirement $or project certification are a3.read-y abridging our freedom of inquiq- in the absence of any cvideiice of hazard ad, therefore, are near-eyaivalent to book-burning epimdes in tile past, I ~iould appreciate it i.f you wotrld transmit this letter LO all. individuals and govei-merit agencies concerned with the regul.ation of reccmbiriant Di?4 rescsrch. 3 am circulating this Letter to some of my coll.caguc~s throughout the cotincry with the requesi. that the37 express tltcir views to you imnediat>ly. Yours respectfully, CYfan Ertcl. Charles Yanofslcy Born in New York City, Apri.1 17, 1925. Received the W.S. degree (Bio- chemistry) fron the City College of New York i-n 1943. Received the M.S. and Ph.D. dcgrees (T.licrobislogy) from Yale University in 1950 aid 1951, respective1.y. Served with the Aimed Forces of the Uni red States 1944-1346. American Society of Nicrobiologists Genetics Socicty of America ,keri.csn iwsocia tion for the Advancement of Science Sigma xi American Society of Xological C;)wij sts Research and/or Professional xerienca: -- _- l_l_-_- Proiesscr, Departnmit of Biologj cnl Sciences, Stanford University Associate Pr-ofessor, Department of EioZogical Sciences , Staniord Unjversity Ass? stant Professor oi Mi crobiology, Western Reserve U;nivercity Pkdical. School Reseal-r h Arsistnnt in MicroblDlogy, Yale IJnivercit-y Irie-3j cal School. 19G1 - present 19 58 -3.9 6 1 1954-1958 19 51- 1953 Awards Honors, and Service : --> President Genetics Society of America, 1969 Career Invrstizator of the American Heart Association, 1969- Appointed Herzstein Professor of Biology, 1967 Lederlc 14edical. Facb! ty Award, 19 55-1957 Eli 1,i 1l.y hmrd in Bnctcri-o!.ogy, 1953 U. S. Srecl Award in Molecular Biology, 1964 Howard Taylor Riclcetts Award, 1366 Albert Lasker Award in Basic Mcdical Research, 1971 National Academy of Sciences Award in Microbial-ogy, 1372 To-msend Harris Medal, CCNY, 1973 Loriisri Gross HOLT~~CZ Prize, 1976